Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis

A Phase 1/2 Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis

The purpose of this study is to evaluate safety and tolerability of VX-121 in healthy subjects and in subjects with cystic fibrosis (CF).

Key Inclusion Criteria:

• Part A, B, and C: Healthy Volunteers

  • Female subjects must be of non-childbearing potential
  • Between the ages of 18 and 55 years, inclusive
  • Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and a total body weight >50 kg

• Part D: Subjects with CF

  • Heterozygous for F508del and an MF mutation (F/MF)
  • FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height
  • Body weight ≥35 kg

Key Exclusion Criteria:

• Part A, B and C: Healthy Volunteers

  • Any condition possibly affecting drug absorption
  • History of febrile illness or other acute illness within 5 days before the first study drug dose

• Part D: Subjects with CF

  • History of clinically significant cirrhosis with or without portal hypertension
  • History of solid organ or hematological transplantation
  • Lung infection with organisms associated with a more rapid decline in pulmonary status

Other protocol defined Inclusion/Exclusion criteria may apply